Important development in diagnosis of Rheumatoid Arthritis

-- Leiden University Medical Center licenses novel diagnostic for Rheumatoid Arthritis to INOVA Diagnostics

LEIDEN, The Netherlands and SAN DIEGO, Jan. 29, 2013 /PRNewswire/ -- Leiden University Medical Center (LUMC) and INOVA Diagnostics are pleased to announce the completion of an exclusive, worldwide license agreement for technology developed at LUMC to detect antibodies to carbamylated proteins (anti-CarP). This technology represents an important advance in the diagnosis of Rheumatoid Arthritis (RA). 

"The detection of autoantibodies in sera of RA patients has provided important insight into the processes that initiate and drive RA. Since anti-CarP antibodies can also be detected in a subgroup of patients for whom so far no serological markers were available we believe this may provide new insight into the pathogenesis of RA, "said Dr. Leendert Trouw, Assistant Professor at LUMC.

"With new treatment options at hand it is now possible to apply early and aggressive treatment. Understanding which patients would benefit most from such an intervention is important to maximize efficiency, and detection of anti-CarP antibodies may identify such patients," said Prof. Tom Huizinga, head of the Department of Rheumatology at LUMC. Prof. Rene Toes, head of the Rheumatology Research Lab adds, "We are trying to understand the disease, RA, and unraveling how the presence of autoantibodies like anti-CarP contribute to RA will make it possible to design novel strategies that may prevent the onset of RA."

"We believe the anti-CarP technology represents a significant advance in the diagnosis of RA, helping to close the serological gap that exists with current biomarkers," said Roger Ingles, CEO of INOVA Diagnostics.(1) "The team at LUMC has an impressive track record in research and biomarker discovery in RA, including the design of the second generation CCP peptide.  We are pleased to partner with this prestigious team to advance the research related to anti-CarP, and commercialize this important new biomarker."

A study published last year by the team at LUMC in Proceedings of the National Academy of Sciences showed that IgG and IgA antibodies recognizing carbamylated antigens were present in about 50% of RA patients.  Anti-CarP antibodies recognize homocitrulline and are therefore distinct from anti-citrullinated protein antibodies (ACPA), including anti-Cyclic Citrullinated Peptide (anti-CCP), a biomarker commonly used to diagnose RA.  Anti-CarP IgG and IgA were detected in 16% and 30% of ACPA negative RA patients respectively.  Additionally, anti-CarP antibodies were shown to be predictive of a more severe course of disease as measured by radiological progression in ACPA negative RA patients.(2,3) 

About Leiden University Medical Center (LUMC)

As a center of medical innovations, the Leiden University Medical Center (LUMC) strives towards an internationally recognized, leading role in the improvement of quality of health care. Core businesses of the LUMC are patient care, research, education and training. The LUMC is part of the Dutch Federation of University Medical Centers (NFU). The NFU is a collaboration of the eight University Medical Centers of the Netherlands. www.lumc.nl

About INOVA Diagnostics, Inc.
INOVA Diagnostics, Inc. is a privately held company headquartered in San Diego, California, which was acquired by Werfen Group in 2008. Werfen Group's in vitro diagnostics (IVD) division also includes Instrumentation Laboratory and Biokit.  INOVA develops and manufactures in vitro medical diagnostic systems and tests for autoimmune disease that are used in medical labs, hospitals and universities around the world, and is a leader in the development and commercialization of new technologies and diagnostic markers in the field of autoimmunity.  Further information about INOVA can be found at www.inovadx.com.

[1-3]

1. Trouw LA, Mahler M. Closing the serological gap: promising novel biomarkers for the early diagnosis of rheumatoid arthritis. Autoimmun. Rev. 2012; 12:318-22.
2. Shi J, Knevel R, Suwannalai P et al. Autoantibodies recognizing carbamylated proteins are present in sera of patients with rheumatoid arthritis and predict joint damage. Proc Natl Acad Sci U S A 2011; 108:17372-7.
3. Shi J, Willemze A, Janssen GM et al. Recognition of citrullinated and carbamylated proteins by human antibodies: specificity, cross-reactivity and the 'AMC-Senshu' method. Ann Rheum Dis. 2012; in press.